Promethazine Hydrochloride
- Product NDC
- 0641-1495
- 11-digit product format
- 006411495
- Labeler code
- 0641
- Product ID
- 0641-1495_80a400d2-d293-4180-bfa7-7a8ce0734bc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 1973-09-19
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992460, 992858 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-1495-31 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION | 1 | | 5 |
| 0641-1495-35 | Promethazine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-1495 | PROMETHAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240412_13d9e59d-eadb-41d5-9f47-9c11a6efb31c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-1495-31 | 00641149531 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 0641-1495-35 | 00641149535 | 25 AMPULE in 1 CARTON (0641-1495-35) / 1 mL in 1 AMPULE (0641-1495-31) | 25 ampule | 1973-09-19 | 0000-00-00 | No | No | Current |